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IOV-4001 for Melanoma and Lung Cancer
Study Summary
This trial will test a new cancer treatment called IOV-4001 on people with melanoma or NSCLC that has spread and can't be removed by surgery. They will be measuring how effective and safe it is.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have melanoma, worsened within 12 weeks after anti-PD-1/PD-L1 treatment, and received BRAF/MEK inhibitors if BRAF positive.I have at least one tumor that can be surgically removed.I have received specific treatments based on my group assignment.My organs are functioning well.I have not had a live vaccine within the last 28 days.I have been diagnosed with advanced melanoma or non-small cell lung cancer.You may need to take a breathing test.I have brain metastases that haven't been treated and are causing symptoms.I am fully active or can carry out light work.I received my last dose of anti-PD-1/PD-L1 therapy less than 12 weeks ago.I have had another type of cancer in the last 3 years.My cancer worsened within 12 weeks after my last anti-PD-1/PD-L1 treatment.I have been diagnosed with advanced melanoma or non-small cell lung cancer.I have had an organ transplant or cell therapy after chemo in the last 20 years.I have received platinum-based chemotherapy.My melanoma originates from the eye.You need to have a test to check how well your heart is working.I need more than 10 mg/day of prednisone or an equivalent steroid.I have at least one tumor that can be measured and was removed for a specific treatment.You have a condition that weakens your immune system from birth.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Cohort 1
- Group 2: Cohort 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are involved in this clinical experiment?
"The sponsor of this trial, Iovance Biotherapeutics Inc., is seeking to enrol a contingent of 53 patients that meet the study's criteria. These individuals will be recruited from locations such as Memorial Sloan Kettering Cancer Center in New york and University of Louisville in Kentucky."
Are there still opportunities for enrolment in this clinical trial?
"Affirmative. Clinicaltrials.gov records support that this clinical trial, which was launched on July 20th 2022, is actively recruiting participants. 53 individuals are needed from 3 locations to complete the study."
What aims is this research endeavor attempting to achieve?
"The primary objective of this study, which will be tracked over a period up to 60 months, is to assess the safety profile of IOV-4001. Secondary endpoints include Disease Control Rate (DCR), Feasibility of IOV-4001 and Overall Survival (OS). Respectively, they measure response rate based on RECIST v1.1 criteria by an investigator, successful manufacturing with no delays or failures, as well as total time from infusion until death due any cause."
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What portion of applicants met pre-screening criteria?
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